Paragraph IV Notice definition

Paragraph IV Notice has the meaning set forth in Section 10.3(a).
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Paragraph IV Notice shall have the meaning set forth in Section 9.7.
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Paragraph IV Notice means any “patent certification” filed in the United States under 21 U.S.C. §355(b)(2)(A)(iv) or §355(j)(2)(A)(vii)(IV), or similar provisions in other jurisdictions.
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Examples of Paragraph IV Notice in a sentence

  • Sun’s Paragraph IV Notice Letter asserts that its generic product will not infringe the listed patents or that the listed patents are invalid or unenforceable.

  • Mylan’s Paragraph IV Notice Letter asserts that its generic product will not infringe the listed patents or that the listed patents are invalid or unenforceable.

  • Lupin’s Paragraph IV Notice Letter asserts that its generic product will not infringe the listed patents or that the listed patents are invalid or unenforceable.

  • Watson’s Paragraph IV Notice Letter asserts that its generic product will not infringe the listed patents or that the listed patents are invalid or unenforceable.

  • Australian artists earned an average of 24.700 Australian dollars (arts plus nonarts work, annual income), their comparable groups earned an average of 30.500 per year.Many studies on the relatively low earnings of artists have been conducted through out the years but the results are not univocal.

  • On November 20, 2012 the Company received a Paragraph IV Notice Letter from Dr. Reddy’s, indicating that Dr. Reddy’s had filed a second ANDA with the FDA seeking regulatory approval to market a generic version of VIMOVO.

  • Anchen’s Paragraph IV Notice Letter asserts that its generic product will not infringe those five listed patents or that those five listed patents are invalid or unenforceable.

  • Each of the Parties shall have the same rights to initiate patent infringement litigation based on a Paragraph IV Notice as are provided in Section 8.3(c).

  • Patent infringement litigation based on a Paragraph IV Notice concerning an Arena Patent or Program Patent shall be brought as provided in Section 9.3(b), with such Paragraph IV Notice being deemed a Field Infringement.

  • Novan will have the right (but not the obligation), at its sole discretion, to take any and all action it deems necessary to stop any Infringement (or respond to any Paragraph IV Notice), including the bringing of an action based on the Novan Patents in the Territory.


More Definitions of Paragraph IV Notice

Paragraph IV Notice has the meaning set forth in Section 12.2.2(iii).
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Paragraph IV Notice means (a) a notice under 21 U.S.C. §355(b)(2)(A)(iv) or 355(j)(2)(A)(vii)(IV) concerning any Product or (b) any substantially similar notice provided under any Applicable Laws outside the U.S.
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Paragraph IV Notice shall have the meaning set forth in Section 5.5.1.
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Paragraph IV Notice concerning an Incyte Product Patent Right, Incyte Program Patent Right or Incyte Patent Right or a Program Patent Right, Pfizer Patent Right, Pfizer Process Patent Claim or Pfizer Use Patent Claim, then it shall use reasonable efforts to provide a copy of such notice to the other Party within two (2) Business Days after its receipt thereof and best efforts to provide such copy as promptly as practicable thereafter. Pfizer shall have the only right, but no obligation, to initiate patent infringement litigation based on a Paragraph IV Notice concerning a Pfizer Patent Right, Pfizer Process Patent Claim or Pfizer Use Patent Claim, at its own expense. Pfizer shall have the first right, but no obligation, to initiate patent infringement litigation based on a Paragraph IV Notice concerning an Incyte Patent Right or a Program Patent Right, at its own expense. If Pfizer fails to initiate such litigation within thirty (30) days of its receipt of the applicable Paragraph IV Notice, then Incyte shall have the right, but no obligation, to initiate such litigation, at Incyte’s expense, but only if such litigation (x) involves an Incyte Compound or Incyte Product and (y) does not involve a Pfizer Product or a Compound that Pfizer has selected for development. Incyte shall have the only right, but no obligation, to initiate patent infringement litigation based on a Paragraph IV Notice concerning an Incyte Product Patent Right or Incyte Program Patent Right. Each Party, upon request of the other Party, shall reasonably cooperate with the requesting Party in any such litigation at the requesting Party’s expense.
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Paragraph IV Notice has the meaning set forth in Section 4.1(k).
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Related to Paragraph IV Notice

  • Xxxxx Notice means the Notice of Grant of Stock Option accompanying the Agreement, pursuant to which Optionee has been informed of the basic terms of the option evidenced hereby.

  • Denial notice means a board notification denying an application for the issuance or renewal of a license as required by the Act.

  • FOIA Notice means a decision notice, enforcement notice and/or an information notice;

  • infringement notice has the meaning set forth in Section 7.4.1;

  • statutory notice means a notice served by the company under the Companies Acts requiring particulars of interests in shares or of the identity of persons interested in shares.

  • CFIUS Notice means a joint voluntary notice with respect to the transactions contemplated by this Agreement prepared by the parties and submitted to CFIUS in accordance with the requirements of the DPA.

  • CAFA Notice refers to the notice requirements imposed by 28 U.S.C. § 1715(b).

  • OJEU Notice means the contract notice published in the Official Journal of the European Union.

  • Renewal Notice As defined in Section 1.4(a).

  • Initial Notice shall have the meaning set forth in Section 7.1.

  • License Period means the period beginning from the Commencement Date and ending on the Termination Date.

  • Third Party Claim Notice shall have the meaning set forth in Section 6.5(a).

  • General Notice means any notice given in accordance with this Agreement other than a Transfer Notice;

  • complaining Party means any Party that requests the establishment of an arbitration panel under Article 3.5 (Initiation of the Arbitration Procedure);

  • Opt-Out Notice has the meaning specified therefor in Section 2.02(a) of this Agreement.

  • Nonrenewal Notice Date has the meaning specified in Section 2.03(b)(iii).

  • Notifying Party As defined in Section 3.01(i).

  • Notice of Breach means a written notice delivered to the other party within the time period required under the definition of “Cause” or “Good Reason,” as applicable, that (a) indicates, as applicable, the specific provision in this Agreement that the party contends the other party has breached or the specific clause of the definition of “Cause” or “Good Reason” that the party alleges to exist, and (b) to the extent applicable, sets forth in reasonable detail the facts and circumstances Executive or the Company, as applicable, claims provide the basis for such breach or other condition.

  • Claims Notice has the meaning set forth in Section 9.3(a).

  • Offeror’s Notice means the notice described in Section 12.3.

  • Notice of Appeal means a notice given pursuant to Condition 6.2.

  • Non-Renewal Notice shall have the meaning set forth in Section 2.

  • Mediation Notice is defined in Section 6.2(b).

  • Privacy Notice means Sage’s privacy notice posted on xxx.xxxx.xxx (or such other URL as Sage may notify to you) and which may be amended by Sage from time to time.

  • Escalation Notice has the meaning set forth in Section 8.02.

  • Second Notice means notice to the Class in a form to be approved by the Court, which shall substantially be in accordance with the notice at Schedule “E”.